Cricothyrostomy instrument

ABSTRACT

An instrument for emergency laryngeal-tracheal operations hereinafter referred to as a cricothyrostomy instrument which includes a cricothyrostomy tube of generally L-shaped configuration with the tube having an access opening through which a cutting instrument may be inserted to penetrate the laryngeal-tracheal wall, preferably the cricothyroid membrane, thus enabling the tube to be inserted in the trachea of the individual to permit an airway to be cleared.

United States Patent [191 Gilbert [11] 3,906,956 14 1' Sept. 23, 1975 CRICOTHYROSTOMY INSTRUMENT [76] Inventor: Max I. Gilbert, 9612 N. Military Trl., Palm Beach Gardens, Fla.

22 Filed: July 3,1974

21 App1.No.:483,727

[52] US. Cl. 128/305.3; 128/351 [51] Int. C1. A61B 17/32; A61M 16/00 [58] Field of Search 128/4, 10, 303 R, 305 R, 128/3053, 347, 351

[56] References Cited UNITED STATES PATENTS 2,657,691 11/1953 Nordstrom,Jr 128/303 R 2,865,374 12/1958 Brown et a1. 128/3053 2,991,787 7/1961 Shelden et a1. 128/351 3,182,663 5/1965 Abelson 128/305 3,476,113 11/1969 Tarsitano 128/351 X 3,556,103 l/l971 Calhoun 128/351 X 3,570,498 3/1971 Weighton... 128/347 3,747,127 7/1973 Taub 128/351 X Primary Exarnimzr-Channing L. Pace Attorney, Agent, or FirmSteele & Petock [57] ABSTRACT An instrument for emergency laryngeal-tracheal operations hereinafter referred to as a cricothyrostomy instrument which includes a cricothyrostomy tube of generally Lshaped configuration with the tube having an access opening through which a cutting instrument may be inserted to penetrate the laryngeal-tracheal wall, preferably the cricothyroid membrane, thus enabling the tube to be inserted in the trachea of the individual to permit an airway to be cleared.

12 Claims, 6 Drawing Figures US Patent Sept. 23,1975 Sheet 1 of2 3,906,956

US Patent sfipt. 23,1975 Sheet 2 on 3,906,956

CRICOTHYROSTOMY INSTRUMENT BACKGROUND OF THE INVENTION 1. Field of the Invention The subject invention relates generally to the performance of tracheotomies and cricothyrostomies and discloses an instrument which, while it can be used advantageously in the performance of either one of the above surgical emergencies, is particularly adapted for performing cricothyrostomies.

Acute respiratory distress is a life threatening situation wherein minutes and seconds literally mean the difference between life and death. By either performing an emergency tracheotomy or cricothyrostomy, the lat ter differing from a tracheotomy in that the entry is made through the cricothyroid membrane, an airway can be opened to a persons trachea to alleviate the acute onset of anoxia or hypoxia where mouth to mouth resuscitation may be impractical of ineffective.

There is a demand for such instruments not only for the performance of operations under ideal surgical conditions but also where a trained surgeon is not available. Paramedics, nurses, ambulance and rescue personnel, and the like, often are confronted with life threatening situations where every minute counts. Present day instruments require perfected techniques and expertise which may be gained only through extensive experience and thus, many in life saving situations are inhibited from taking responsibility where positive un* hesitating action is critical to success.

2 Prior Art In the past, devices used for surgically gaining access to a persons trachea primarily have been tracheotomy instruments of a standard configuration. The most widely used instruments comprise an arcuate hollow tube which is used in conjunction with an arcuate tro' car instrument extendable therethrough which is used to make the incision. Various types of such instruments are shown in U.S. Pat. Nos. 2,865,374 Brown et al, 2,991,787 Shelden et al. and 3,556,103 Calhoun. As shown in Brown et al and Shelden et al, the arcuate trocar instrument has a cutting portion with blade elements perpendicular to one another to cut a cruciate incision. One of the disadvantages of such an instrument when used in surgical procedures, is that an excessive amount of bleeding is likely to result as contrasted to where a simple linear penetration is achieved.

Further, the arcuate structure of the tube and trocar of the prior art patents is significantly deficient in at least one very important phase of its use. The instrument is extremely difficult to handle because of the shape of the trocar giving rise to the necessity to insert it very slowly and precisely as the incision is made. Improper angulation during penetration is likely to result in the cutting of the posterior tracheal membrane which is very soft tissue.

In Pat. No. 3,476,l l3 Tarsitano, a cricothyrostomy set is disclosed which is used to penetrate a cricothyroid membrane and to provide access to the trachea at this location. While there are advantages which will be discussed in making entry at this location,

the Tarsitano device does not disclose an instrument SUMMARY OF THE INVENTION Accordingly, it is an object of the subject invention to provide a cricothyrostomy instrument which is uniquely designed for use to penetrate the cricothyroid membrane and to be insertable into the patients tra chea to provide an emergency airway.

It is another object of the subject invention to pro vide a cricothyrostomy instrument which may be used by relatively untrained and unskilled medical or lay personnel for performing cricothyrostomies and in the alternative, tracheotomies in emergency situations.

It is another object of the subject invention to provide a cricothyrostomy instrument which has improved airway means by having dual openings in the portion of the tube which will be inserted into the patients trachea.

It is yet another object of the subject invention to provide a cricothyrostomy instrument in which a straight cutting instrument or trocar instrument may be used to provide ease and safety during penetration and to reduce the likelihood of improper angulation.

It is still another object of the subject invention to provide a cricothyrostomy instrument which is uniquely designed in cross-section to take advantage of the most advantageous position of entry into a persons trachea. I

It is yet another object of the subject invention to provide a cricothyrostomy instrument which may be effective with or without the use of a positive pressure unit.

It is but one more object of the subject invention to provide a cricothyrostomy instrument which has a sliding adaptor to prevent a shifting in position once the instrument is inserted.

It is one more object of the subject invention to provide a cricothyrostomy instrument in which the cutting or trocar instrument has an improved cutting blade to minimize bleeding and other effects during penetration.

In accordance with the above objects, a laryngeal tracheal or cricothyrostomy instrument is provided which includes two major components. The first is a cricothyrostomy tube which is generally L-shaped and which has an access opening in the proximity of the vertex angle of the L to permit entry of the second major component which is a straight knife or cutting instrument referred to as a trocar. While the instrument may be used anywhere in the laryngeal-tracheal region, it is specifically designed for use in the cricothyroid space and is of oval configuration to better take advantage of anatomical characteristics of all patients. The cricothyroid space is the most superficial area of the laryngeal-tracheal region which makes it the most accessible approach to use and one which is easily located by prominent easily palpated charaeterisitcs even in obese patients. In this area, there is less likelihood of hemorrhage and since it is superficial, there is no deep soft tissue damage during penetration.

The use of a straight trocar or knife increases the control over the unit and enables paramedics and other individuals to use the instrument in emergency situations. Once penetration is achieved, the tube, because of its general configuration, may be easily slid into the trachea preferably through the cricoid space since another advantage of this location is in the event the instrument contacts the posterior membrane, there is additional cricoid cartilage to prevent the instrument from penetrating the posterior portion of the trachea. After the tube is inserted and enters the trachea, the knife member can be easily withdrawn. When the tube is advanced, the dual openings in the tube through which the knife member passed, can be positioned within the tracheal portion to increase the air flow.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows the cricothyrostomy instrument as it is penetrating through the cricothyroid membrane of a patient;

FIG. 2 shows the cricothyrostomy tube as it is being advanced after the knife member has been withdrawn;

FIG. 3 discloses thecricothyrostomy tube in position after having been adjusted to its fully operative position;

FIG. 4 is a cross-sectional view of a portion of the cricothyrostomy tube taken through section lines 4-4 of FIG. 3; I

FIG. 5 is a perspective view of the instrument show ing the cutting member removed from the cricothyrostomy tube; and g I FIG. 6 is a perspective view of a cricothyrostomy tube ofan alternate embodiment.

DETAILED DESCRIPTION I With reference toFlGS. l-3, the laryngeal-tracheal region of the anatomic structure of a patient is shown. The thyroid cartilage A is directly above the cricothyroid membrane B and the cricoid cartilage C. The trachea D is shownsurroundcd by tracheal rings E.

The laryngeal-tracheal or cricothyrostomy instrument is shown generally as 10 and comprises a cricothyrostomy tube member 12 and a cutting instrument 24 which are seen in perspective in FIG. 5. The tube 10 is in part an ovoid hollow member having three segments I4, 16 and 18 whith each succeeding segment being approximately 45 to the proceeding segment. An overall L-shaped configuration thus results. The opening at the end of tube 14 will be designated as the advance opening 13. At the opposite end the tube 10 may terminate in a cylindrical portion 20 with portion 22 being transitional. This enables the tube 10 to be adaptable to standard positive pressure units (not shown) which may be utilized to provide air under pressure. An access entry way 15, the purpose of which will be subsequently described. is located in the tube 12 and may be entirely within middle segment 16 as shown in FIG. I. The ovoid shape of segments 14, I6 and 18 of the tube is to be emphasized as is shown in FIG. 4 and is important since the cricothyroid space is of similar configuration.

With further reference to FIGS. 1 and 5, the cutting instrument or trocar 24 is shown as comprising an ovoid cutting member 26 which terminates in a cutting edge 28. Atthe opposite end from the cutting edge 28, a guiding portion 30 is disclosed which serves as both a guiding means with surface 3l serving as a thumb rest; and a restraining means to limit the extent of entry of the cutting member 26 into tube 10.

With further reference to FIGS. 1-4 and 5, a restraining member 32 which may be adjustable, is used to position the cricothyrostomy tube 10 at a desired operational position once the insertion is accomplished. The restraining member 32 may be a friction slide device as shown in FIG. 1 or in thealternative, it may have adjustable screw or clamp means. Furthermore, the restraining member 32 may be eliminated and the transition portion 22 may serve as a guard to prevent the instrument from being inserted too far into the patient. As shown in FIG. 2, the cutting instrument 24 has been withdrawn and the tube is being advanced. While the tube is functional in FIG. 2, the ultimate fully operational position is shown in FIG. 3.

In using the cricothyrostomy instrument and with reference first to FIG. 1, the cutting instrument 24 is inserted through access opening 15 and through the first segment 14 of the tubing, projecting slightly outwardly of advance opening 13 (see FIG, 5). Penetration is achieved with the first segment 14 and cutting member 26 held perpendicular to the cricothyroid membrane. A pistol grip may be used with the thumb resting on thumb surface 31 of the cutting instrument 24 while the fingers grip segment 18 of the cricothyrostomy tube 12. With the neck extended, penetration of the cricothyroid membrane is achieved and the instrument 10 advanced to the first angulated segment 16 of the tube. The cutting instrument 24 is then withdrawn through the access opening 15 in the second angulated segment 16 and it is at this time that the patient may begin to breathe. The cricothyrostomy tube 12 is then lifted and guided gently as the angulated portion 16 is inserted further with the first segment 14 being urged downwardly into the trachea as shown in FIG. 2. Next, the third segment 18 is likewise advanced to the point where the first segment 14 of the tube is approximately in the mid-trachea as shown in FIG. 3. It is to be noted that each segment is inserted as it is perpendicular to the neck. The optional adjustable end 32 may be used to secure the tube 12 to maintain the position asshown in FIG. 3.

A standard positive pressure device may then be connected to tube portion 20 although this may not be critical for survival. It is noted at this operational position both the advance opening 13 and access entry way 15 are within the trachea to provide dual openings therein to increase the air flow to the patient. Either the restraining member 32, or the transitional area 22 may be used to secure the instrument at its operational position. The cricothyroid anatomical configuration is of generally ovoid configuration and accommodates the tube 12 with a minimum of hemorrhaging due to the simple linear slit that was made by the cutting edge 28.

Thus, it is advantageous to use the instrument in the cricothyroid area and optimum benefits are obtained with the use of the ovoid configuration since it takes full advantage of the natural anatomical surrounding structure and permits the largest airway possible. Effectively, the cross-sectional area is roughly twice that of the cross-sectional area of a circular cylinder of the largest diameter that the eircothyroid area could receive. Since during stress conditions, a patients need for air increases drastically. the advantage of utilizing tubing of maximum cross-sectional area can be readily appreciated. In this light, it will be appreciated that the subject instruments may be of various sizes to be best suited for patients having different physical size charactcristics.

By using. the instrument in the cricothyroid area, advantage is also takcn of the posterior segment of the cricoid cartilage which is not easily penetrated, thus aiding in the prevention of damage to the laryngeal tracheal wall and further reducing the possibility of delayed complications from penetration and infection. In addition, the cricothyroid space is the most superficial area of the laryngeal-tracheal region and is thus the most accessible approach. Tissue damage and the likelihood of hemorrhaging are also reduced in this area.

In an alternate embodiment shown in FIG. 5, the ericothyrostomy tube 48 has been modified and as shown is L-shaped with components 50 and 52 joining at essentially a right angle with optional angle portion 54 being rounded to facilitate the full insertion of the tube 48. An access opening 56 is shown in the vertex region which accommodates a cutting instrument 60 similar to that shown in FIGS. 1 and 5. The modified tube 48 and its accommodating cutting member may be circular in cross-section, as shown, however, if the instrument is to be used in the cricothyroid region, it preferably should be of ovoid configuration. A protective widened end 58 similar to that of the previous em bodimcnt may be employed but is optional if other restraining means and positive pressure receiving means are utilized.

While a wide range of materials may be used for the above embodiments of the tube and cutting member, the use of polyethylene or equivalent for the tube and metal such as stainless steel for the cutting member is contemplated.

While various embodiments of the invention have been shown and described, it will be understood that other modifications may be made. The appended claims, therefore, are intended to define the true scope of the invention.

What is claimed is:

l. A laryngeal-tracheal instrument comprising:

a tube of generally L-shaped configuration having tubular components joining to form a vertex region and including an access opening through structure of said vertex region; and

a cutting instrument, a portion of which is slidably engageable through said access opening and through one of said tubular components whereby said cutting instrument is insertable through said tube to penetrate a membrane in the laryngeal tracheal region of a patient.

2. The laryngeal-tracheal instrument of claim 1 wherein said tube is ovoid in crosssection and a portion of said cutting instrument is ovoid in cross-section.

3. The laryngeal-tracheal instrument of claim 1 wherein the cutting instrument has a cutting edge.

4. The laryngeal-tracheal instrument of claim 1 wherein said cutting instrument comprises a straight ovoid member having restraining structure including a thumb rest portion at one of its extremities.

5. The laryngeal-tracheal instrument of claim 1 including means by which said tube may be joined to a positive pressure source.

6. The laryngeal-tracheal instrument of claim 1 further including a restraining member secured to one of the components of said tube and adjustable to be positioned against a patients anatomical structure of a portion of the laryngeal-tracheal region.

7. A ericothyrostomy instrument comprising: a ericothyrostomy tube having a first ovoid portion, a second ovoid portion .angulated thereto and a 5 third ovoid portion angulaated to the second ovoid portion, said second ovoid portion having an access means therethrough, said first and third ovoid portions having open ends; and a cutting instrument having an ovoid cutting member 0 with a piercing end, said ovoid cutting member slidably engageable through said access means and into said first ovoid component whereby said cutting instrument is insertable through said cricothyrostomy tube to penetrate a membrane in the laryngeal-tracheal region.

8. A laryngeal-tracheal instrument comprising an open ended tube otherwise closed throughout except for an access opening through the tubular wall; and

a straight cutting instrument designed to enter said tube first through said access opening and then through one of said open ends whereby the laryngeal-tracheal membrane may be penetrated by said cutting instrument and said tube may be inserted to provide an air passageway to an individuals trachea.

9. The method of conducting a ericothyrostomy on a patient comprising the steps of:

inserting a cutting instrument through a first opening of a ericothyrostomy tube and advancing the instrument to project outwardly of a second opening in the ericothyrostomy tube;

penetrating the cricothyroid membrane with the cutting instrument;

inserting a first portion of the ericothyrostomy tube through said membrane;

withdrawing the cutting instrument; and

further inserting said ericothyrostomy tube whereby said first and second openings of said ericothyrostomy tube are positioned in a patients trachea.

10. The method of claim 9 further including the step of securing the ericothyrostomy tube with a restraining member positioned against the external laryngealtracheal region of the patient.

11. The method of claim 10 wherein the step of further inserting said ericothyrostomy tube comprises the steps of:

advancing a second portion of said ericothyrostomy tube which is angulated with respect to said first portion inserted; and

advancing a third portion of said ericothyrostomy tube which is angulated with respect to the second portion.

12. The method of claim 11 wherein the steps of inserting and further inserting are carried out while the portion of the tube being inserted is perpendicular to the outer surface of the patient where said insertion is occurring. 

1. A laryngeal-tracheal instrument comprising: a tube of generally L-shaped configuration having tubular components joining to form a vertex region and including an access opening through structure of said vertex region; and a cutting instrument, a portion of which is slidably engageable through said access opening and through one of said tubular components whereby said cutting instrument is insertable through said tube to penetrate a membrane in the laryngealtracheal region of a patient.
 2. The laryngeal-tracheal instrument of claim 1 wherein said tube is ovoid in cross-section and a portion of said cutting instrument is ovoid in cross-section.
 3. The laryngeal-tracheal instrument of claim 1 wherein the cutting instrument has a cutting edge.
 4. The laryngeal-tracheal instrument of claim 1 wherein said cutting instrument comprises a straight ovoid member having restraining structure including a thumb rest portion at one of its extremities.
 5. The laryngeal-tracheal instrument of claim 1 including means by which said tube may be joined to a positive pressure source.
 6. The laryngeal-tracheal instrument of claim 1 further including a restraining member secured to one of the components of said tube and adjustable to be positioned against a patient''s anatomical structure of a portion of the laryngeal-tracheal region.
 7. A cricothyrostomy instrument comprising: a cricothyrostomy tube having a first ovoid portion, a second ovoid portion angulated thereto and a third ovoid portion angulated to the second ovoid portion, said second ovoid portion having an access means therethrough, said first and third ovoid portions having open ends; and a cutting instrument having an ovoid cutting member with a piercing end, said ovoid cutting member slidably engageable through said access means and into said first ovoid component whereby said cutting instrument is insertable through said cricothyrostomy tube to penetrate a membrane in the laryngeal-tracheal region.
 8. A laryngeal-tracheal instrument comprising an open ended tube otherwise closed throughout except for an access opening through the tubular wall; and a straight cutting instrument designed to enter said tube first through said access opening and then through one of said open ends whereby the laryngeal-tracheal membrane may be penetrated by said cutting instrument and said tube may be inserted to provide an air passageway to an individual''s trachea.
 9. The method of conducting a cricothyrostomy on a patient comprising the steps of: inserting a cutting instrument through a first opening of a cricothyrostomy tube and advancing the instrument to project outwardly of a second opening in the cricothyrostomy tube; penetrating the cricothyroid membrane with the cutting instrument; inserting a first portion of the cricothyrostomy tube through said membrane; withdrawing the cutting instrument; and further inserting said cricothyrostomy tube whereby said first and second openings of said cricothyrostomy tube are positioned in a patient''s trachea.
 10. The method of claim 9 further including the step of securing the cricothyrostomy tube with a restraining member positioned against the external laryngeal-tracheal region of the patient.
 11. The method of claim 10 wherein the step of further inserting said cricothyrostomy tube comprises the steps of: advancing a second portion of said cricothyrostomy tube which is angulated with respect to said first portion inserted; and advancing a third portion of said cricothyrostomy tube which is angulated with respect to the second portion.
 12. The method of claim 11 wherein the steps of inserting and further inserting are carried out while the portion of the tube being inserted is perpendicular to the outer surface of the patient where Said insertion is occurring. 